F
hi,
I wonder what if a company in UE produces medical device class I (without measure and not sterile) and I will buy this medical device under my name and my graphic on labels? Who am I? OBL or OEM?
And what if this medical device is not the same as originally produced by the manufacuter? What if is it similar, but not the same? Who am I? OEM?
I wonder what documentation I should receive from the manufacturer who What documents should I receive from them when I am OEM and when I am OBL? Which are necessary for me to prepare technical documentation?
And what about clinical data?
Many thanks for help.

I wonder what if a company in UE produces medical device class I (without measure and not sterile) and I will buy this medical device under my name and my graphic on labels? Who am I? OBL or OEM?
And what if this medical device is not the same as originally produced by the manufacuter? What if is it similar, but not the same? Who am I? OEM?
I wonder what documentation I should receive from the manufacturer who What documents should I receive from them when I am OEM and when I am OBL? Which are necessary for me to prepare technical documentation?
And what about clinical data?
Many thanks for help.